Application Forms 1 - 14

ATTACHMENT 1

APPLICATION FORMS 1 - 14

Form 1

Insert signed copies for subcontracting organizations behind the applicant face page.

Face Page

Project Title (Do not exceed 60 characters and spaces)
Application Type: CART  IDEA  Postdoctoral Fellowship 
Mentored Research Scientist  Mentored Clinical Scientist  / NEW 
REVISED 
Principal Investigator #1
Last Name, First Name, Middle Initial Degree(s) / Co-Principal Investigator/Mentor #2
Last Name, First Name, Middle Initial Degree(s)
Institution / Institution
Department / Department
Mailing Address (Street, MS, PO Box, City, State, Zip) / Mailing Address (Street, MS, PO Box, City, State, Zip)
Phone / Fax / Phone / Fax
E-mail / E-mail
Type of Organization:  Public  Federal  State  Local  Private Nonprofit  For Profit
Federal Employer ID # (9 digits): / DUNS Number:
Charities Registration Number (or “Exempt category”):
F&A Costs:  DHHS Agreement Date: ______ DHHS Agreement being Negotiated  No DHHS Agreement, but rate established (explain and date):
Human Subjects / YES  NO  / Vertebrate Animals / YES  NO 
Project Duration / Yr One Grand total Costs / Grand Total Costs
New York State Applicant Organization / Research Performing Sites
Mailing Address (Street, MS, PO Box, City, State, Zip)
Contracts and Grants Official / Official Signing for Organization
Mailing Address
(Street, PO Box, MS, City, State, Zip) / Mailing Address
(Title and Organization, Street, MS, PO Box, City, State, Zip)
Phone / Fax / Phone / Fax
E-mail / E-mail
Address where reimbursement should be sent if contract is awarded (street, MS,PO Box, city, NY, Zip):
CERTIFICATION AND ASSURANCE: I certify that the statements herein are true and complete to the best of my knowledge. I agree to accept responsibility for the scientific conduct and integrity of the research, and to provide the required progress reports if a contract is awarded as a result of this application.
SIGNATURES OF PRINCIPAL INVESTIGATOR and CO-PI/MENTOR (“Per” not allowed)
#1 X / DATE:
#2 X / DATE:
ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that the statements herein are true and complete to the best of my knowledge, and I accept the obligation to comply with the New York State Spinal Cord Injury Research Board's terms and conditions if a contract is awarded as a result of this application.
SIGNATURE OF THE OFFICAL SIGNING FOR THE APPLICANT ORGANIZATION (“Per” not allowed)
X / DATE:

Form 1

Insert signed copies for subcontracting organizations behind the applicant face page.

Table of Contents

This form is required and may be used as a checklist.

Form / Form Name / Page
1 / Face Page / 1
1 / Face Page - Subcontracting Organization(s)
2 / Table of Contents
3 / Scientific Abstract
4 / Lay Abstract
5 / Program Responsiveness
6 / Budget
7 / Personnel and Budget Justification
6 / Budget –Subcontracting Organization(s)
7 / Personnel and Budget Justification – Subcontracting Organization(s)
8 / Biographical Sketch(es)
9 / Facilities and Resources
10 / Other Support
Revisions and Comments (Required for ‘Revised Applications’, See Section V.C) 
11 / Research Plan
Specific Aims
Significance
Background and Preliminary Results
Research Design and Methods
Literature Cited - Not included in page limitations
12 / Time Line and Collaboration Strategy
13 / Human Subjects - Required if ‘YES’ checked on Face Page
14 / Vertebrate Animals - Required if ‘YES’ checked on Face Page

 Indicate “N/A” if not applicable.

Form 2

Scientific Abstract

Present the information requested. Use available space to your best advantage; comply with font guidelines.

Research Areas: Identify key words that best describe the research areas addressed in your application. Sample key words include: (1) Acute Injury Events and Processes; (2) Regeneration and Development; (3) Reinnervation; (4) Transplantation/Grafting; (5) Intervention and Prosthetics; (6) Translational or Clinical Research or (7) Other – (specify).

Background:

Hypothesis:

Objectives/Aims:

Methods:

Impact on Treatments or Cures for Spinal Cord Injury Paralysis:

Form 3

Not to exceed one page.

Lay Abstract

Present the information requested below in non-technical terms. Use available space to your best advantage; comply with font guidelines.

Introduction/Background to the Research Topic:

The Question(s) or Central Hypothesis of the Research:

The General Methodology to be Used: (If pluripotent stem cells, indicate specific cell line and source)

Innovative Elements of the Project:

Impact on Treatments or Cures for Spinal Cord Injury Paralysis: (Do not overstate this section.)

Form 4

Not to exceed one page.

Program Responsiveness

Clearly describe the application of diverse fields applying complementary approaches to work on an important well-defined problem and discuss the increased synergy and effectiveness gained from combining the specific projects proposed. Describe future plans to bring anticipated research results to the next developmental stage. Include a discussion of the evolution of models to be used in such future investigations (i.e., cell culture, invertebrate models, vertebrate models, non-human primates, or humans).

Form 5

Not to exceed one page.

Budget

BUDGET CATEGORY / Year
One / Year
Two / Year Three (CART or Mentored only) / Year Four (CART only) / TOTAL
(all years)
PERSONAL SERVICE (PS)
1 / SALARY AND STIPENDS
2 / FRINGE BENEFITS
3 / SUBTOTAL PS
OTHER THAN PERSONAL SERVICE (OTPS)
4 / SUPPLIES
5 / EQUIPMENT
6 / TRAVEL
7 / CONSULTANT COSTS
8 / OTHER EXPENSES
9 / SUBTOTAL OTPS
10 / TOTAL PS & OTPS
11 / TOTAL SUBCONTRACT COSTS (line 14 of subcontractor budgets)
12 / TOTAL DIRECT COSTS
(sum of lines 10 + 11)
13 / FACILITIES AND ADMINISTRATIVE COSTS
14 / GRAND TOTAL COSTS
(sum of lines 12 + 13)

Form 6

Attach subcontractor budgets using additional copies of Form 6.

Personnel Effort and Budget Justification

Key Personnel * / Percent FTE / Dollar Amount Requested (Year One)
Name / Role in
Project / Appt. / On
Project / For Salary Requested / Salary / Fringe / Total
Support Personnel * / Percent FTE / Dollar Amount Requested (Year One)
Name / Role in
Project / Appt. / On
Project / For Salary Requested / Salary / Fringe / Total
Total Salary + Fringe Requested – should equal Year One, line 3, Form 6.

* Insert additional lines as necessary under Key Personnel or Support Personnel.

Describe the items to be included in Other than Personal Service Costs.

Form 7

Not to exceed two pages per organization. Attach subcontractor Personnel Effort and Budget Justification using additional copies of Form 7.

Biographical Sketch

NAME / POSITION/TITLE
EDUCATION/TRAINING (Begin with baccalaureate or other professional education, and include postdoctoral training)
INSTITUTION AND LOCATION / DEGREE / YEAR(s) / FIELD OF STUDY

A. Positions and Honors. List in chronological order all previous positions, concluding with your present position. List any honors. Include present membership on any Federal Government public advisory committee.

B. Selected peer-reviewed publications or manuscripts in press (in chronological order). Do not include manuscripts submitted or in preparation. For publicly available citations, URLs or PMC submission identification numbers may accompany the full reference.

Form 8

Not to exceed two pages per individual. Present the PI first, followed by Co-PI(s) and the remaining key personnel in alphabetical order using additional copies of Form 8.

Facilities and Resources

FACILITIES: Specify the facilities to be used to conduct the proposed research. Indicate the performance site(s) and describe pertinent site capabilities, relative proximity and extent of availability to the project. Under “Other”, identify support services such as machine shop and electronics shop, and specify the extent to which such services will be available to the project. Use one additional continuation page, if necessary.

Laboratory:

Clinical:

Animal:

Computer:

Office:

Other:

MAJOR EQUIPMENT: List the most important equipment items already available for this project, noting the location and pertinent capabilities of each.

Form 9

Not to exceed two pages per collaborating institution.

Other Support

Name of Key Personnel:

Check if there is no other research support for the individual listed: 

TITLE OF PROJECT:  Pending  Active

PROJECT PI:

FUNDING AGENCY/GRANT ID NO.:

PERIOD OF SUPPORT: % FTE

THIS PROJECT INVOLVES SPINAL CORD INJURY-RELATED RESEARCH:  *Yes  No

THIS PROJECT OVERLAPS A RESEARCH AIM IN THIS APPLICATION:  *Yes  No

Form 10

Repeat the format presented above for each project. Use additional pages as needed. Present the principal investigator first, followed by Co-PI(s) and the remaining key personnel in alphabetical order. For any “Yes” answer, explain the distinction between the project and this application, directly below the item. Indicate a possible resolution, if this application is funded.

Form 11

Follow all page limitations, font and margin requirements.

Research Plan

A. Specific Aims

B. Significance

C. Background and Preliminary Results

D. Research Design and Methods

E. Literature Cited

Form 11

Follow all page limitations, font and margin requirements.

Time Line and Collaboration Strategy

Aim / Investigator Responsible
Name of Institution / Activities / Time Frame

If this application involves an inter-institutional collaboration, describe strategies for information and/or resource exchange to ensure the efficient and effective completion of the project.

Form 12

Human Subjects

This form is required only for projects to which protections for use of human subjects on the face page.

 Ethnically/Racially diverse populations included.

 Ethnically/Racially diverse populations excluded.

Complete separate tables for ALL human subjects protocols to be used with the grant application if funded. Present information from the applicant organization first, followed by subcontracting or consortium organizations. It is the responsibility of the applicant organization to ensure that all performance sites comply with the regulations in 45 CFR Part 46 and all other statutes, regulations or policies pertaining to human subject participants and tissues.

Institution:

Institutional OHRP Federal-wide Assurance of Compliance Number:

IRB Approval Status:  Approved  Pending  Exemption #

Protocol Number: Principal Investigator:

Project Title:

Approval Date: Are you listed as an approved investigator on this protocol:  Yes  No

Does your institution require annual (or more frequent) reviews of this protocol:  Yes  No

If “Yes”, date of next review:

Repeat table as often as necessary.

If the IRB Approval Status (above) is Pending or Approved, attach a narrative to address the eight points listed below (see Section V.A. Application Contents).

1. Involvement of Human Subjects and Population Characteristics

2. Sources of Materials – Confidentiality

3. Risks

4. Recruitment and Consent

5. Protection from Risk

6. Potential Benefits of the Proposed Research to the subjects and others

7. Importance of the Knowledge to be Gained

8. Education

Form 13

Use additional sheets as necessary, following font and margin requirements.

Form 13

Use additional sheets as necessary, following font and margin requirements.

Vertebrate Animals

This form is required only for applications that checked “Yes” for vertebrate animals on the face page.

Complete separate tables for ALL vertebrate animal protocols to be used with the grant application if funded. Present information from the applicant organization first, followed by subcontracting or consortium organizations.

Institution:

Institutional Animal Care & Use Number:

NYS DOH Animal Care & Use Certificate Number: _

USDA Registration Number (if applicable to species):

Vertebrate Animal Approval Status:  Approved Pending

Protocol Number: Principal Investigator:

Project Title:

Approval Date: Are you listed as an approved investigator on this protocol:  Yes  No

Does your institution require annual (or more frequent) reviews of this protocol:  Yes  No

If “Yes”, date of next review:

Repeat table as often as necessary.

All applications proposing vertebrate animal research are required to address the four points below. Acquisition and use of animals at all performance sites must comply with New York State Public Health Law, Article 5, Title I, Sections 504 and 505-a.

1. Description of proposed animal use

2. Justification

3. Description of procedures to ensure that discomfort, distress, pain and injury will be limited

4. Description of any method of euthanasia

Form 14

Use additional sheets as necessary, following font and margin requirements.

ATTACHMENT 2

Sample Letter of Interest

Letter to Receive RFA Updates and Modifications

DOH Contact

DOH Address

Re: RFA #

RFA Title

Dear ______:

This letter is to indicate our interest in the above Request for Applications (RFA) and to request that our organization be placed on the mailing list: (please check one)

ÿ To be notified when any updates, written responses to questions, or amendments to the RFA are posted on the official Department of Health website http://www.health.ny.gov/funding/

ÿ To receive actual documents of any updates, written responses to questions, or amendments to the RFA.

Please use the following address to send the notification/documentation: (please check one)

ÿ E-mail address: ______

ÿ Street Address: ______

______

Sincerely,

ATTACHMENT 3

APPLICATION CHECKLIST

Mandatory items are indicated by bold text.

ð 2 original signed copies of the application Face Page (Attachment 1 – Form 1)

ð 1 CD-ROM containing a single DOC or single PDF containing the entire application

6 paper copies of the following:

ð Attachment 1 - Forms 2-12

ð Human Subjects (Attachment 1 – Form 13) – and include the 8-point narrative If the IRB has not deemed the project to be Exempt prior to submission of the application

ð Vertebrate Animals (Attachment 1 – Form 14) - If vertebrate animals or tissues are to be used, Form 14 must be completed (including the 4 points listed)

ð Vendor Responsibility Attestation (Attachment 4)

For Revised Applications ONLY:

ð “Revised Application” checked on Face Page (Attachment 1 – Form 1)

ð Must have the same Principal Investigator as the original application

ð “Revisions and Comments” section immediately preceding Research Plan indicating changes made and responses to comments from the previous review

ð Includes responses to criticisms in the previous review

Appendices: